CA3025405C - Testing device for checking at least one first medical electrode - Google Patents
Testing device for checking at least one first medical electrode Download PDFInfo
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- CA3025405C CA3025405C CA3025405A CA3025405A CA3025405C CA 3025405 C CA3025405 C CA 3025405C CA 3025405 A CA3025405 A CA 3025405A CA 3025405 A CA3025405 A CA 3025405A CA 3025405 C CA3025405 C CA 3025405C
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/36125—Details of circuitry or electric components
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01R—MEASURING ELECTRIC VARIABLES; MEASURING MAGNETIC VARIABLES
- G01R27/00—Arrangements for measuring resistance, reactance, impedance, or electric characteristics derived therefrom
- G01R27/02—Measuring real or complex resistance, reactance, impedance, or other two-pole characteristics derived therefrom, e.g. time constant
- G01R27/26—Measuring inductance or capacitance; Measuring quality factor, e.g. by using the resonance method; Measuring loss factor; Measuring dielectric constants ; Measuring impedance or related variables
- G01R27/2605—Measuring capacitance
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/08—Arrangements or circuits for monitoring, protecting, controlling or indicating
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
- A61N1/39—Heart defibrillators
- A61N1/3925—Monitoring; Protecting
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01R—MEASURING ELECTRIC VARIABLES; MEASURING MAGNETIC VARIABLES
- G01R31/00—Arrangements for testing electric properties; Arrangements for locating electric faults; Arrangements for electrical testing characterised by what is being tested not provided for elsewhere
- G01R31/50—Testing of electric apparatus, lines, cables or components for short-circuits, continuity, leakage current or incorrect line connections
- G01R31/58—Testing of lines, cables or conductors
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
- A61B2560/02—Operational features
- A61B2560/0266—Operational features for monitoring or limiting apparatus function
- A61B2560/0276—Determining malfunction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/0404—Electrodes for external use
- A61N1/0408—Use-related aspects
- A61N1/046—Specially adapted for shock therapy, e.g. defibrillation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N2001/37294—Means for testing medical devices within the package prior to implantation
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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- Biomedical Technology (AREA)
- Animal Behavior & Ethology (AREA)
- Radiology & Medical Imaging (AREA)
- Engineering & Computer Science (AREA)
- General Physics & Mathematics (AREA)
- Physics & Mathematics (AREA)
- Heart & Thoracic Surgery (AREA)
- Neurology (AREA)
- Cardiology (AREA)
- Neurosurgery (AREA)
- Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)
Abstract
The invention relates to a testing device for checking at least one first medical electrode (1), wherein the testing device comprises at least one first measuring electrode (2), which can be arranged relative to the first medical electrode (1) to be checked in such a way that the at least one first measuring electrode (2) and the first medical electrode (1) to be checked form a first capacitance (C11); a signal generating device (3), by way of which an alternating current voltage can be generated, by means of which the first capacitance (Cn) can be acted upon; an evaluation device (4), which is designed to determine at least one first test result (P11) in relation to the first capacitance (C11) from a measured impedance curve (I) of an impedance caused in response to the first capacitance (C11).
Description
TESTING DEVICE FOR CHECKING AT LEAST ONE FIRST MEDICAL ELECTRODE
The invention relates to a testing device for checking at least one medical electrode.
Electrodes to be checked emerge, for example, in US 2015/0045869 Al. This discloses two jointly assembled medical electrodes in the form of defibrillation electrodes.
Previous testing devices functioned on a purely manual basis, in that the presence of a contact between connections of the electrode and the actual electrode surface (conducting surface) was visually checked by an employee and the electrical connection was determined by means of a multimeter. The test step was to be provided separately to the value-adding processes. Such a procedure is error-prone and complex.
The object of the invention is to provide a testing device which allows at least partially automated testing, which can take place during a value-adding process.
According to an aspect of the present invention, there is provided a testing device for checking at least one first medical electrode, the testing device comprising:
at least one first measuring electrode, which can be arranged relative to the at least one first medical electrode to be checked, wherein the at least one first measuring electrode and the at least one first medical electrode to be checked form a first capacitance a signal generating device, for generating an alternating voltage, by means of which the first capacitance can be acted upon, and an evaluation device, which is designed to determine at least one first test result in relation to the first capacitance from a measured first impedance curve of a first impedance caused in response to the first capacitance, wherein the testing device further comprises at least one second measuring electrode, which can be arranged relative to the at least one first medical electrode to be checked, wherein the at least one second measuring electrode and the at least one first medical electrode to be checked form a second capacitance, and the evaluation device is designed to determine at least one second test result in relation to the second capacitance from a measured second impedance curve of a second impedance caused due to the second capacitance in response to the alternating voltage generated by the signal generating device.
Date Recue/Date Received 2021-02-22
The invention relates to a testing device for checking at least one medical electrode.
Electrodes to be checked emerge, for example, in US 2015/0045869 Al. This discloses two jointly assembled medical electrodes in the form of defibrillation electrodes.
Previous testing devices functioned on a purely manual basis, in that the presence of a contact between connections of the electrode and the actual electrode surface (conducting surface) was visually checked by an employee and the electrical connection was determined by means of a multimeter. The test step was to be provided separately to the value-adding processes. Such a procedure is error-prone and complex.
The object of the invention is to provide a testing device which allows at least partially automated testing, which can take place during a value-adding process.
According to an aspect of the present invention, there is provided a testing device for checking at least one first medical electrode, the testing device comprising:
at least one first measuring electrode, which can be arranged relative to the at least one first medical electrode to be checked, wherein the at least one first measuring electrode and the at least one first medical electrode to be checked form a first capacitance a signal generating device, for generating an alternating voltage, by means of which the first capacitance can be acted upon, and an evaluation device, which is designed to determine at least one first test result in relation to the first capacitance from a measured first impedance curve of a first impedance caused in response to the first capacitance, wherein the testing device further comprises at least one second measuring electrode, which can be arranged relative to the at least one first medical electrode to be checked, wherein the at least one second measuring electrode and the at least one first medical electrode to be checked form a second capacitance, and the evaluation device is designed to determine at least one second test result in relation to the second capacitance from a measured second impedance curve of a second impedance caused due to the second capacitance in response to the alternating voltage generated by the signal generating device.
Date Recue/Date Received 2021-02-22
2 According to another aspect of the present invention, there is provided use of a testing device as described above, which is separate from the skin of the patient, for checking at least one medical electrode before it is applied to the skin of the patient.
According to another aspect of the present invention, there is provided use of a testing device as described above, for testing the at least one first medical electrode together with connecting cables(s) of the at least one first medical electrode, wherein the alternating voltage from the signal generating device is applied to the at least one first medical electrode via the connecting cable(s).
According to another aspect of the present invention, there is provided use of a testing device as described above, for testing the at least one first medical electrode together with connecting cable(s) of the at least one first medical electrode and present connector plugs, wherein the alternating voltage from the signal generating device is applied to the at least one first medical electrode via the connecting cable(s) and the connector plug(s).
According to another aspect of the present invention, there is provided use of a testing device as described above for checking the at least one first medical electrode, wherein the at least one first medical electrode is located in a closed package.
The testing device according to an aspect of the invention operates without the production of a mechanical electrical contact between the medical electrode(s) to be checked and the measuring electrode(s). The testing process itself can be carried out fully automatically and the testing device can be fitted at least partially automatically.
A single (first) measuring electrode for carrying out the testing process is sufficient per se. In order to increase the safety (in particular safety against incorrect operation and manipulation safety and measurement stability of the test) the arrangement of at least one second measuring electrode can be provided. Only when the evaluation unit determines in relation to the signals of both resulting capacitances that the medical electrode has passed the test is the latter released. In such an embodiment, it is provided that - the testing device further has at least one second measuring electrode, which can be arranged relative to the first medical electrode to be checked, in that the at least one Date Recue/Date Received 2022-01-31
According to another aspect of the present invention, there is provided use of a testing device as described above, for testing the at least one first medical electrode together with connecting cables(s) of the at least one first medical electrode, wherein the alternating voltage from the signal generating device is applied to the at least one first medical electrode via the connecting cable(s).
According to another aspect of the present invention, there is provided use of a testing device as described above, for testing the at least one first medical electrode together with connecting cable(s) of the at least one first medical electrode and present connector plugs, wherein the alternating voltage from the signal generating device is applied to the at least one first medical electrode via the connecting cable(s) and the connector plug(s).
According to another aspect of the present invention, there is provided use of a testing device as described above for checking the at least one first medical electrode, wherein the at least one first medical electrode is located in a closed package.
The testing device according to an aspect of the invention operates without the production of a mechanical electrical contact between the medical electrode(s) to be checked and the measuring electrode(s). The testing process itself can be carried out fully automatically and the testing device can be fitted at least partially automatically.
A single (first) measuring electrode for carrying out the testing process is sufficient per se. In order to increase the safety (in particular safety against incorrect operation and manipulation safety and measurement stability of the test) the arrangement of at least one second measuring electrode can be provided. Only when the evaluation unit determines in relation to the signals of both resulting capacitances that the medical electrode has passed the test is the latter released. In such an embodiment, it is provided that - the testing device further has at least one second measuring electrode, which can be arranged relative to the first medical electrode to be checked, in that the at least one Date Recue/Date Received 2022-01-31
3 second measuring electrode and the first medical electrode to be checked form a second capacitance, - the evaluation device is designed to determine at least one second test result in relation to the second capacitance from a measured second impedance curve of a second impedance caused due to the second capacitance in response to an alternating voltage generated by the signal generating device.
In this case, in some embodiments, it can preferably be provided that the surfaces of the at least one first and the at least one second measuring electrode are different sizes. This allows two different release windows to be used in relation to the one medical electrode to be tested, even when only one alternating voltage is used with one frequency.
The first and the second measuring electrodes can be arranged arbitrarily per se in relation to the electrode to be checked (for example side by side).
However, in order to achieve a compact arrangement, in some embodiments, it is preferably provided that the at least one first measuring electrode is in the form of a first circular ring and the at least one second measuring electrode is arranged within the first circular ring and is electrically isolated from the first circular ring by a first insulator.
In some embodiments, it is preferably provided that the testing device is designed for joint or simultaneous checking of at least one first medical electrode and a second medical electrode. For example, defibrillation electrodes have a pair of electrodes, and other medical electrodes can be combined in a smaller (in other words, in isolation) or in a larger number to form a functional unit. In this embodiment, the testing device further has:
- at least one third measuring electrode, which can be arranged relative to the second medical electrode to be checked such that the at least one third measuring electrode and the second medical electrode to be checked form a third capacitance, wherein - the signal generating device is designed to generate an alternating voltage by means of which the third capacitance can be acted upon - the evaluation device, which is designed to determine at least one third test result in relation to the third capacitance from a measured third impedance curve of a third impedance Date Recue/Date Received 2022-01-31
In this case, in some embodiments, it can preferably be provided that the surfaces of the at least one first and the at least one second measuring electrode are different sizes. This allows two different release windows to be used in relation to the one medical electrode to be tested, even when only one alternating voltage is used with one frequency.
The first and the second measuring electrodes can be arranged arbitrarily per se in relation to the electrode to be checked (for example side by side).
However, in order to achieve a compact arrangement, in some embodiments, it is preferably provided that the at least one first measuring electrode is in the form of a first circular ring and the at least one second measuring electrode is arranged within the first circular ring and is electrically isolated from the first circular ring by a first insulator.
In some embodiments, it is preferably provided that the testing device is designed for joint or simultaneous checking of at least one first medical electrode and a second medical electrode. For example, defibrillation electrodes have a pair of electrodes, and other medical electrodes can be combined in a smaller (in other words, in isolation) or in a larger number to form a functional unit. In this embodiment, the testing device further has:
- at least one third measuring electrode, which can be arranged relative to the second medical electrode to be checked such that the at least one third measuring electrode and the second medical electrode to be checked form a third capacitance, wherein - the signal generating device is designed to generate an alternating voltage by means of which the third capacitance can be acted upon - the evaluation device, which is designed to determine at least one third test result in relation to the third capacitance from a measured third impedance curve of a third impedance Date Recue/Date Received 2022-01-31
4 caused due to the third capacitance in response to the alternating voltage generated by the signal generating device.
Naturally, joint or simultaneous checking can be carried out in such a way that the signal .. generating device successively acts upon the individual capacitances with the alternating voltage and/or that the evaluation device successively measures the impedance curves in relation to the individual capacitances. However, no mechanical manipulation of the medical electrodes to be checked is required in the event of joint or simultaneous checking.
In some embodiments, it is preferably provided that the application of the alternating voltage to at least one of the existing capacitances can be generated in such a way that the signal generating device acts upon the first and/or the second medical electrode(s) to be checked.
The testing device itself can preferably be designed in such a way that the testing device has at least one receiving region, preferably in the form of a planar supporting surface, which is designed to receive at least one, preferably a plurality of, medical electrode(s) to be checked, wherein the measuring electrode(s) is/are arranged in the receiving region.
The electrode to be checked or the electrode pair to be checked can thereby simply be placed on the receiving region, whereupon the capacitive measurement is then carried out.
To connect the electrodes to the signal generating device it can advantageously be provided that at least one electrical connecting element, which is preferably connected to the signal generating device, is preferably arranged in the region of a receiving region for at least one electrode to be checked, to which element at least one connector plug of a connecting cable leading to the medical electrode can be detachably connected.
With a design of this kind the connector plug of the connecting cable of the electrode to be checked is simply inserted into the fixed connecting element and is thereby electrically connected to the signal generating device.
Overall, the testing device according to some embodiments of the invention can be used to check not only the medical electrode itself, but also the connecting cable or conducting connection thereof.
Date Recue/Date Received 2022-01-31 4a In the case of two or more electrodes, the correctness (polarity) of the connecting cables can also be checked in any connector plugs. This is particularly advantageous when, in the case of two electrodes, two connecting cables lead to a double connector plug which has mechanical means in order to be used, for example, only in the correct position, in other words in the correct polarity, in an ECG device. If the connecting cables of the two electrodes were interchanged, the polarity would be wrong and the testing device according to the invention would detect this fault. This wrongly connected double electrode is then rejected and is not attached to the skin of a patient, in particular a human one.
One aspect of the invention provides the use of a testing device, which is separate from the skin of the patient, for checking at least one medical electrode before it is applied, for example adhesively bonded, to the skin of the patient.
There are already capacitive testing devices which test the transition impedance of a medical electrode to the skin of the patient in the adhesively bonded state of the electrode. However, this is not a testing device for the electrodes themselves, but a testing device for correct adhesion to the skin. According to the inventive use, electrodes or pairs of electrodes that are defective or incorrect in polarity are not used at all and can already be segregated beforehand.
As already mentioned, the testing device according to the invention not only checks the electrode itself in a preferred use, but also the connecting cable thereof or optionally present connector plugs. The totality of the electrode, connecting cable, connector plug, as sold as a unit, in particular in a package, is therefore capacitively checked even before being attached to the skin of the patient.
Examples of embodiments of the invention will be discussed with reference to the figures, in which:
Fig. 1 shows a section through the exploded view of Fig. 2 Fig. 2 shows an exploded view of a first example embodiment of a testing device according to the invention Date Recue/Date Received 2022-01-31 4b Fig. 3 shows a schematic representation of a testing device according to an example embodiment of the invention Fig. 4 shows a section through the exploded view of Fig. 5 Fig. 5 shows an exploded view of a second example embodiment of a testing device according to the invention Fig. 6 shows a schematic circuit diagram of the testing device The reference numerals C11, C12, C21, C22 are used below for the first to fourth capacitance, which can be present between different medical electrodes to be checked and different measuring electrodes. The use of different short designations naturally does not mean that the numerical values of the different capacitances cannot be the same.
The first exemplary embodiment of a testing device according to the invention, which is shown in Fig. 1 and 2, is suitable for joint testing of two medical electrodes (a first and a second medical electrode 1, 1') and, more precisely, in each case with two measuring Date Recue/Date Received 2022-01-31
Naturally, joint or simultaneous checking can be carried out in such a way that the signal .. generating device successively acts upon the individual capacitances with the alternating voltage and/or that the evaluation device successively measures the impedance curves in relation to the individual capacitances. However, no mechanical manipulation of the medical electrodes to be checked is required in the event of joint or simultaneous checking.
In some embodiments, it is preferably provided that the application of the alternating voltage to at least one of the existing capacitances can be generated in such a way that the signal generating device acts upon the first and/or the second medical electrode(s) to be checked.
The testing device itself can preferably be designed in such a way that the testing device has at least one receiving region, preferably in the form of a planar supporting surface, which is designed to receive at least one, preferably a plurality of, medical electrode(s) to be checked, wherein the measuring electrode(s) is/are arranged in the receiving region.
The electrode to be checked or the electrode pair to be checked can thereby simply be placed on the receiving region, whereupon the capacitive measurement is then carried out.
To connect the electrodes to the signal generating device it can advantageously be provided that at least one electrical connecting element, which is preferably connected to the signal generating device, is preferably arranged in the region of a receiving region for at least one electrode to be checked, to which element at least one connector plug of a connecting cable leading to the medical electrode can be detachably connected.
With a design of this kind the connector plug of the connecting cable of the electrode to be checked is simply inserted into the fixed connecting element and is thereby electrically connected to the signal generating device.
Overall, the testing device according to some embodiments of the invention can be used to check not only the medical electrode itself, but also the connecting cable or conducting connection thereof.
Date Recue/Date Received 2022-01-31 4a In the case of two or more electrodes, the correctness (polarity) of the connecting cables can also be checked in any connector plugs. This is particularly advantageous when, in the case of two electrodes, two connecting cables lead to a double connector plug which has mechanical means in order to be used, for example, only in the correct position, in other words in the correct polarity, in an ECG device. If the connecting cables of the two electrodes were interchanged, the polarity would be wrong and the testing device according to the invention would detect this fault. This wrongly connected double electrode is then rejected and is not attached to the skin of a patient, in particular a human one.
One aspect of the invention provides the use of a testing device, which is separate from the skin of the patient, for checking at least one medical electrode before it is applied, for example adhesively bonded, to the skin of the patient.
There are already capacitive testing devices which test the transition impedance of a medical electrode to the skin of the patient in the adhesively bonded state of the electrode. However, this is not a testing device for the electrodes themselves, but a testing device for correct adhesion to the skin. According to the inventive use, electrodes or pairs of electrodes that are defective or incorrect in polarity are not used at all and can already be segregated beforehand.
As already mentioned, the testing device according to the invention not only checks the electrode itself in a preferred use, but also the connecting cable thereof or optionally present connector plugs. The totality of the electrode, connecting cable, connector plug, as sold as a unit, in particular in a package, is therefore capacitively checked even before being attached to the skin of the patient.
Examples of embodiments of the invention will be discussed with reference to the figures, in which:
Fig. 1 shows a section through the exploded view of Fig. 2 Fig. 2 shows an exploded view of a first example embodiment of a testing device according to the invention Date Recue/Date Received 2022-01-31 4b Fig. 3 shows a schematic representation of a testing device according to an example embodiment of the invention Fig. 4 shows a section through the exploded view of Fig. 5 Fig. 5 shows an exploded view of a second example embodiment of a testing device according to the invention Fig. 6 shows a schematic circuit diagram of the testing device The reference numerals C11, C12, C21, C22 are used below for the first to fourth capacitance, which can be present between different medical electrodes to be checked and different measuring electrodes. The use of different short designations naturally does not mean that the numerical values of the different capacitances cannot be the same.
The first exemplary embodiment of a testing device according to the invention, which is shown in Fig. 1 and 2, is suitable for joint testing of two medical electrodes (a first and a second medical electrode 1, 1') and, more precisely, in each case with two measuring Date Recue/Date Received 2022-01-31
5' =
electrodes (in relation to the first medical electrode 1 to be checked, these are the first measuring electrode and the second measuring electrode 2, 5 and in relation to the second medical electrode 1 to be checked these are the third and fourth measuring electrodes 7, 8).
The four capacitances C11 C12, C21, C22 are present during the test.
The testing device has a receiving region 16, which is designed here for simultaneously receiving two medical electrodes 1, 1 'to be tested. The medical electrodes 1, 1 ' to be tested should be arranged in the receiving region 16 in such a way that their actual electrode surfaces (conducting surfaces) point away from the receiving region 16. The back sides of the medical electrodes 1 to be checked 1, 1' are fixed for testing by way of vacuum (the openings 12 are used for applying the same). Therefore, there is no direct electrical contact between the conducting surfaces of the medical electrodes 1, 1' to be checked and the measuring electrodes 2,5,7, 8. If there is a desire to arrange the medical electrodes 1, 1' to be tested with their front sides in the receiving region 16, separate insulators would have to be arranged between the conducting surfaces and the measuring electrodes.
The second exemplary embodiment of a testing device according to the invention, which is shown in Fig. 4 and 5, is suitable for testing a medical electrode 1 and has two measuring electrodes 2, 5. These are arranged side by side, but could also be designed in the same way as in the exemplary embodiment in Fig. 1 and 2. The two capacitances C11, C12 are present during the test. The support 9 can therefore be designed as in the exemplary embodiment of Fig. 1 and 2.
The connecting cable 21 for the medical electrode 1, at the free end of which a connector plug 22 is provided, can be seen in the exemplary embodiment illustrated in Fig. 2. The connector plug is merely schematically illustrated.
A connecting element 23 is arranged next to the receiving region 16 for the medical electrode to be checked, into which element the connector plug 22 can be inserted for checking. The signal generating device can then act upon the medical electrode, in particular with an alternating voltage, via the connecting element 23, the inserted connector plug 22 and the connecting cable 21.
The connecting cable and the connector plug 22, in addition to the electrode 1 itself, are checked for functional capability, in particular electrical conductivity, by means of this testing device.
electrodes (in relation to the first medical electrode 1 to be checked, these are the first measuring electrode and the second measuring electrode 2, 5 and in relation to the second medical electrode 1 to be checked these are the third and fourth measuring electrodes 7, 8).
The four capacitances C11 C12, C21, C22 are present during the test.
The testing device has a receiving region 16, which is designed here for simultaneously receiving two medical electrodes 1, 1 'to be tested. The medical electrodes 1, 1 ' to be tested should be arranged in the receiving region 16 in such a way that their actual electrode surfaces (conducting surfaces) point away from the receiving region 16. The back sides of the medical electrodes 1 to be checked 1, 1' are fixed for testing by way of vacuum (the openings 12 are used for applying the same). Therefore, there is no direct electrical contact between the conducting surfaces of the medical electrodes 1, 1' to be checked and the measuring electrodes 2,5,7, 8. If there is a desire to arrange the medical electrodes 1, 1' to be tested with their front sides in the receiving region 16, separate insulators would have to be arranged between the conducting surfaces and the measuring electrodes.
The second exemplary embodiment of a testing device according to the invention, which is shown in Fig. 4 and 5, is suitable for testing a medical electrode 1 and has two measuring electrodes 2, 5. These are arranged side by side, but could also be designed in the same way as in the exemplary embodiment in Fig. 1 and 2. The two capacitances C11, C12 are present during the test. The support 9 can therefore be designed as in the exemplary embodiment of Fig. 1 and 2.
The connecting cable 21 for the medical electrode 1, at the free end of which a connector plug 22 is provided, can be seen in the exemplary embodiment illustrated in Fig. 2. The connector plug is merely schematically illustrated.
A connecting element 23 is arranged next to the receiving region 16 for the medical electrode to be checked, into which element the connector plug 22 can be inserted for checking. The signal generating device can then act upon the medical electrode, in particular with an alternating voltage, via the connecting element 23, the inserted connector plug 22 and the connecting cable 21.
The connecting cable and the connector plug 22, in addition to the electrode 1 itself, are checked for functional capability, in particular electrical conductivity, by means of this testing device.
6 Fig. 3 shows very schematically the construction of a testing device in accordance with the invention according to the first exemplary embodiment, having:
- a first and a second measuring electrode 2, 5, which can be arranged relative to the first medical electrode 1 to be checked such that the first measuring electrode 2 and the first medical electrode 1 to be checked form a first capacitance C11 and the second measuring electrode 5 and the first medical electrode 1 to be checked form a second capacitance C12 - a third and a fourth measuring electrode 7, 8, which can be arranged relative to the second medical electrode 1' to be checked such that the third measuring electrode 7 and the second medical electrode 1' to be checked form a third capacitance C21 and the fourth .. measuring electrode 8 and the second medical electrode 1' to be checked form a fourth capacitance C22 - a signal generating device 3, by way of which an alternating voltage can be generated, by means of which the first to fourth capacitance C11, C12, C21, C22 can be acted upon - an evaluation device 4, which is designed to determine a first to fourth test result P11, P12, P21, P22 in relation to the first to fourth capacitance C11, C12, C21, C22 and to determine an overall test result P in relation to the first to fourth capacitance Cii, C12, C21, C22 from a measured impedance curve l, 112, 121, 122 of an impedance caused in response to the first to fourth capacitance C11, C12, C21, C22.
In the exemplary embodiment illustrated in Fig. 3 the connecting cables 21, 21' and their connector plugs 22, 22' can likewise be checked, wherein the connector plugs 22, 22' can be inserted into connecting elements 23, 23'.
As indicated by dashed lines, the connector plugs 22, 22' can be connected to a double connector plug which has two electrical connections. The same applies to the connection elements 23, 23'. These can likewise be connected to a double connection element.
Mechanical aligning means which are known per se can then preferably be provided and these ensure that the double connector plug 22, 22 ' is not inserted into the double connection element 23, 23 'in an inverted manner. Aligning means of this kind are known to the person skilled in the art, for example, connecting pins of different sizes or asymmetrical projections or grooves on the plug can be used in order to avoid an inverted insertion. Once =
- a first and a second measuring electrode 2, 5, which can be arranged relative to the first medical electrode 1 to be checked such that the first measuring electrode 2 and the first medical electrode 1 to be checked form a first capacitance C11 and the second measuring electrode 5 and the first medical electrode 1 to be checked form a second capacitance C12 - a third and a fourth measuring electrode 7, 8, which can be arranged relative to the second medical electrode 1' to be checked such that the third measuring electrode 7 and the second medical electrode 1' to be checked form a third capacitance C21 and the fourth .. measuring electrode 8 and the second medical electrode 1' to be checked form a fourth capacitance C22 - a signal generating device 3, by way of which an alternating voltage can be generated, by means of which the first to fourth capacitance C11, C12, C21, C22 can be acted upon - an evaluation device 4, which is designed to determine a first to fourth test result P11, P12, P21, P22 in relation to the first to fourth capacitance C11, C12, C21, C22 and to determine an overall test result P in relation to the first to fourth capacitance Cii, C12, C21, C22 from a measured impedance curve l, 112, 121, 122 of an impedance caused in response to the first to fourth capacitance C11, C12, C21, C22.
In the exemplary embodiment illustrated in Fig. 3 the connecting cables 21, 21' and their connector plugs 22, 22' can likewise be checked, wherein the connector plugs 22, 22' can be inserted into connecting elements 23, 23'.
As indicated by dashed lines, the connector plugs 22, 22' can be connected to a double connector plug which has two electrical connections. The same applies to the connection elements 23, 23'. These can likewise be connected to a double connection element.
Mechanical aligning means which are known per se can then preferably be provided and these ensure that the double connector plug 22, 22 ' is not inserted into the double connection element 23, 23 'in an inverted manner. Aligning means of this kind are known to the person skilled in the art, for example, connecting pins of different sizes or asymmetrical projections or grooves on the plug can be used in order to avoid an inverted insertion. Once =
7 the double connector plug 22, 22 ' has been inserted into the double connection element 23, 23 ' in the correct position, the testing device according to the invention can then determine whether the connecting cable from the connector plug really leads to the electrode 1 and not (incorrectly) to the electrode 1'. In this way the correctness of the polarity of the double electrode 1, 1' can be checked irrespective of the conductivity of the connecting cables and the correct electrode structure per se.
Fig. 6 shows a detailed representation of Fig. 3. It can be seen that the signal generating device 3 comprises a frequency generator 17 and a clock 18. The frequency generator 17 acts upon the two medical electrodes 1, 1' to be checked with an alternating voltage. The clock 18 has an output A and an output B. The output A is associated with the first medical electrode 1 to be checked and is linked via an AND element 14 to an output of the frequency generator 17 associated with the first medical electrode 1 to be checked. The output B is associated with the second medical electrode 1' to be checked and is linked via an AND
element 14 to an output of the frequency generator 17 associated with the second medical electrode 1' to be checked. This ensures that the two medical electrodes 1, 1' to be checked are not acted upon simultaneously by the alternating voltage.
The outputs A, B of the clock 18 are furthermore each linked to a flip-flop 20 of the evaluation device 4. It is therefore possible to assign from which of the two medical electrodes 1, 1' to be checked test signals are arriving.
Each of the four capacitances Cu, C12, C21, C22 is part of a resonant circuit 19 with an inductance and an electrical resistance (for the sake of clarity, only one of the resonant circuits is provided with the reference numeral 19).
The impedance curve 111, 112, 121, 122 resulting from the applied alternating voltage in each resonant circuit 19 is supplied to an analysis device 13 of the evaluation device 4 which checks whether the impedance curve lit 112, 121, 122 is in a predetermined window. If this is the case, the respective analysis device 13 outputs a positive test result P
= 11, = P
P P 12, = 21, = 22. A test result is formed for each of the medical electrodes 1, 1' to be checked via an AND element 14. An overall test result P for both medical electrodes 1, 1 to be checked is formed via a further AND element 14 and output via the output 15.
=
7a The testing device according to the invention is particularly suitable for use as a testing device separate from the skin of the patient for checking at least one medical electrode before its application to the skin of the patient. Medical electrodes that are found to be faulty can then already be rejected in advance and are not used at all on the patient. With the testing device according to the invention it is possible to check not only the electrode itself but also its connecting cable and its connector plug, in particular also in the case of a double 'CA 03025405 2018-11-23
Fig. 6 shows a detailed representation of Fig. 3. It can be seen that the signal generating device 3 comprises a frequency generator 17 and a clock 18. The frequency generator 17 acts upon the two medical electrodes 1, 1' to be checked with an alternating voltage. The clock 18 has an output A and an output B. The output A is associated with the first medical electrode 1 to be checked and is linked via an AND element 14 to an output of the frequency generator 17 associated with the first medical electrode 1 to be checked. The output B is associated with the second medical electrode 1' to be checked and is linked via an AND
element 14 to an output of the frequency generator 17 associated with the second medical electrode 1' to be checked. This ensures that the two medical electrodes 1, 1' to be checked are not acted upon simultaneously by the alternating voltage.
The outputs A, B of the clock 18 are furthermore each linked to a flip-flop 20 of the evaluation device 4. It is therefore possible to assign from which of the two medical electrodes 1, 1' to be checked test signals are arriving.
Each of the four capacitances Cu, C12, C21, C22 is part of a resonant circuit 19 with an inductance and an electrical resistance (for the sake of clarity, only one of the resonant circuits is provided with the reference numeral 19).
The impedance curve 111, 112, 121, 122 resulting from the applied alternating voltage in each resonant circuit 19 is supplied to an analysis device 13 of the evaluation device 4 which checks whether the impedance curve lit 112, 121, 122 is in a predetermined window. If this is the case, the respective analysis device 13 outputs a positive test result P
= 11, = P
P P 12, = 21, = 22. A test result is formed for each of the medical electrodes 1, 1' to be checked via an AND element 14. An overall test result P for both medical electrodes 1, 1 to be checked is formed via a further AND element 14 and output via the output 15.
=
7a The testing device according to the invention is particularly suitable for use as a testing device separate from the skin of the patient for checking at least one medical electrode before its application to the skin of the patient. Medical electrodes that are found to be faulty can then already be rejected in advance and are not used at all on the patient. With the testing device according to the invention it is possible to check not only the electrode itself but also its connecting cable and its connector plug, in particular also in the case of a double 'CA 03025405 2018-11-23
8 electrode having a double connector plug, since the correctness of the polarity can be checked.
The medical electrode, including the connecting cables and connector plugs, can be checked before packaging thereof into a packaging sleeve, so rejected electrodes are not packaged from the outset. However, it is also conceivable to check the electrodes within a (part) packaging since the capacitive test can in principle take place through the packaging sleeve.
=
The medical electrode, including the connecting cables and connector plugs, can be checked before packaging thereof into a packaging sleeve, so rejected electrodes are not packaged from the outset. However, it is also conceivable to check the electrodes within a (part) packaging since the capacitive test can in principle take place through the packaging sleeve.
=
9 List of reference numerals 1 first medical electrode to be checked 1' second medical electrode to be checked 2 first measuring electrode 3 signal generating device 4 evaluation device 5 second measuring electrode 6 first/second insulator 7 third measuring electrode 8 fourth measuring electrode 9 support
10 space for electrically contacting the measuring electrodes
11 receiving opening for measuring electrodes
12 openings for applying a vacuum
13 analysis device
14 AND element
15 output
16 medical electrode(s) receiving region
17 frequency generator
18 clock
19 resonant circuit
20 flip-flop
21,21' connecting cable
22, 22' connector plug
23, 23' connection element Cl I first capacitance (between a first medical electrode to be checked and a first measuring electrode) C12 second capacitance (between a first medical electrode to be checked and a second measuring electrode) C21 third capacitance (between a second medical electrode to be checked and a third measuring electrode C22 fourth capacitance (between a second medical electrode to be checked and a fourth measuring electrode) 111 first impedance curve 112 second impedance curve 10 121 third impedance curve 122 fourth impedance curve Pi I first test result (in relation to a first electrode to be checked and a first measuring electrode) P12 second test result (in relation to a first electrode to be checked and a second measuring electrode) P21 third test result (in relation to a second electrode to be checked and a first measuring electrode) P22 fourth test result (in relation to a second electrode to be checked and a second measuring electrode) overall test result
Claims (41)
1. A testing device for checking at least one first medical electrode, the testing device comprising:
- at least one first measuring electrode, which can be arranged relative to the at least one first medical electrode to be checked, wherein the at least one first measuring electrode and the at least one first medical electrode to be checked form a first capacitance - a signal generating device, for generating an alternating voltage, by means of which the first capacitance can be acted upon, and - an evaluation device, which is designed to determine at least one first test result in relation to the first capacitance from a measured first impedance curve of a first impedance caused in response to the first capacitance, wherein - the testing device further comprises at least one second measuring electrode, which can be arranged relative to the at least one first medical electrode to be checked, wherein the at least one second measuring electrode and the at least one first medical electrode to be checked form a second capacitance, and - the evaluation device is designed to determine at least one second test result in relation to the second capacitance from a measured second impedance curve of a second impedance caused due to the second capacitance in response to the alternating voltage generated by the signal generating device.
- at least one first measuring electrode, which can be arranged relative to the at least one first medical electrode to be checked, wherein the at least one first measuring electrode and the at least one first medical electrode to be checked form a first capacitance - a signal generating device, for generating an alternating voltage, by means of which the first capacitance can be acted upon, and - an evaluation device, which is designed to determine at least one first test result in relation to the first capacitance from a measured first impedance curve of a first impedance caused in response to the first capacitance, wherein - the testing device further comprises at least one second measuring electrode, which can be arranged relative to the at least one first medical electrode to be checked, wherein the at least one second measuring electrode and the at least one first medical electrode to be checked form a second capacitance, and - the evaluation device is designed to determine at least one second test result in relation to the second capacitance from a measured second impedance curve of a second impedance caused due to the second capacitance in response to the alternating voltage generated by the signal generating device.
2. The testing device according to claim 1, wherein surfaces of the at least one first and the at least one second measuring electrode are different sizes.
3. The testing device according to claim 2, wherein the at least one first measuring electrode is designed as a first circular ring and the at least one second measuring electrode is arranged within the first circular ring and is electrically isolated from the first circular ring by a first insulator.
4. The testing device according to any one of claims 1 to 3, wherein the testing device is designed to jointly check the at least one first medical electrode and a second medical electrode, and further comprises:
- at least one third measuring electrode, which can be arranged relative to the second medical electrode to be checked, wherein the at least one third measuring electrode and the second medical electrode to be checked form a third capacitance, wherein - the signal generating device is designed to generate the alternating voltage, by means of which the third capacitance can be acted upon, and - the evaluation device is designed to determine at least one third test result in relation to the third capacitance from a measured third impedance curve of a third impedance caused due to the third capacitance in response to the alternating voltage generated by the signal generating device.
- at least one third measuring electrode, which can be arranged relative to the second medical electrode to be checked, wherein the at least one third measuring electrode and the second medical electrode to be checked form a third capacitance, wherein - the signal generating device is designed to generate the alternating voltage, by means of which the third capacitance can be acted upon, and - the evaluation device is designed to determine at least one third test result in relation to the third capacitance from a measured third impedance curve of a third impedance caused due to the third capacitance in response to the alternating voltage generated by the signal generating device.
5. The testing device according to claim 4, wherein - the testing device further comprises at least one fourth measuring electrode, which can be arranged relative to the second medical electrode to be checked, wherein the at least one fourth measuring electrode and the second medical electrode to be checked form a fourth capacitance, and - the evaluation device is designed to determine at least one fourth test result in relation to the fourth capacitance from a measured fourth impedance curve of a fourth impedance caused due to the fourth capacitance in response to the alternating voltage generated by the signal generating device.
6. The testing device according to claim 5, wherein surfaces of the at least one third and the at least one fourth measuring electrode are different sizes.
7. The testing device according to claim 6, wherein the at least one third measuring electrode is designed as a second circular ring and the at least one fourth measuring electrode is arranged within the second circular ring and is electrically isolated from the second circular ring by a second insulator.
8. The testing device according to any one of claims 5 to 7, wherein an application of the alternating voltage to at least one of the first, the second, the third and the fourth capacitance can be generated in such a way that the signal generating device acts upon one of or both the first and the second medical electrode to be checked.
9. The testing device according to claim 8, wherein the evaluation device is connected to one or more of the at least one first, the at least one second, the at least one third and the at least one fourth measuring electrode.
10. The testing device according to claim 4, wherein an application of the alternating voltage to at least one of the first, second and third capacitances can be generated in such a way that the signal generating device acts upon one of or both the at least one first medical electrode and the second medical electrode to be checked.
11. The testing device according to claim 10, wherein the evaluation device is connected to one or more of the at least one first, the at least one second and the at least one third measuring electrode.
12. The testing device according to any one of claims 1 to 3, wherein an application of the alternating voltage to at least one of the first and second capacitances can be generated in such a way that the signal generating device acts upon one of or both the at least one first medical electrode and a second medical electrode to be checked.
13. The testing device according to claim 12, wherein the evaluation device is connected to one of or both (1) the at least one first measuring electrode and (2) the at least one second measuring electrode.
14. The testing device according to claim 1, wherein an application of the alternating voltage to the first capacitance can be generated in such a way that the signal generating device acts upon the at least one first medical electrode to be checked.
15. The testing device according to claim 14, wherein the evaluation device is connected to the at least one first measuring electrode.
16. The testing device according to any one of claims 1 to 15, wherein the evaluation device has at least one analysis device which checks whether a measured impedance profile of an associated capacitance lies within a predetermined test window and, if this is the case, considers a test result corresponding to the respective capacitance as positive.
17. The testing device according to claim 16, wherein the evaluation device has an element which emits a positive overall test result for the at least one first medical electrode or a totality of all medical electrodes to be checked only when all test results are considered positive.
18. The testing device according to any one of claims 1 to 17, wherein the testing device has at least one receiving region, designed to receive the at least one first medical electrode to be checked, wherein the measuring electrode(s) is/are arranged in the receiving region.
19. The testing device according to claim 18, wherein the at least one receiving region is in the form of a planar support surface.
20. The testing device according to claim 18, wherein the at least one receiving region is designed to receive a plurality of medical electrodes.
21. The testing device according to any one of claims 18 to 20, wherein at least one opening is arranged in the receiving region in order to apply a vacuum to the at least one first medical electrode to be checked.
22. The testing device according to any one of claims 1 to 21, wherein at least one electrical connection element is provided, wherein the at least one electrical connection element is configured to be detachably connected to at least one connector plug of a connecting cable leading to the at least one first medical electrode.
23. The testing device according to claim 22 when dependent on any one of claims 4 to 10, wherein the connecting cable leads to both the at least one first medical electrode and to the second medical electrode.
24. The testing device according to any one of claims 4 to 10, wherein at least one electrical connection element is provided, wherein the at least one electrical connection element is configured to be detachably connected to at least one connector plug of a connecting cable leading to the second medical electrode.
25. The testing device according to any one of claims 1 to 17, wherein at least one electrical connection element is provided, wherein the at least one electrical connection element is configured to be detachably connected to at least one connector plug of a connecting cable leading to the at least one first medical electrode, wherein the testing device has at least one receiving region, designed to receive the at least one first medical electrode to be checked, and wherein the measuring electrode(s) is/are arranged in the receiving region.
26. The testing device according to claim 25 when dependent on any one of claims 4 to 10, wherein the connecting cable leads to both the at least one first medical electrode and to the second medical electrode.
27. The testing device according to any one of claims 4 to 10, wherein at least one electrical connection element is provided, wherein the at least one electrical connection element is configured to be detachably connected to at least one connector plug of a connecting cable leading to the second medical electrode, wherein the testing device has at least one receiving region, designed to receive one of or both (1) the at least one first medical electrode to be checked and (2) the second medical electrode to be checked, and wherein the measuring electrode(s) is/are arranged in the receiving region.
28. The testing device according to any one of claims 25 to 27, wherein the at least one receiving region is in the form of a planar support surface.
29. The testing device according to any one of claims 25 to 27, wherein the at least one receiving region is designed to receive a plurality of medical electrodes.
30. The testing device according to any one of claims 25 to 29, wherein at least one opening is arranged in the at least one receiving region in order to apply a vacuum to the at least one medical electrode to be checked.
31. The testing device according to any one of claims 25 to 30, wherein the at least one electrical connection element is arranged in a vicinity of the at least one receiving region for the at least one first medical electrode to be checked.
32. The testing device according to any one of claims 1 to 17, wherein at least one electrical connection element is provided, wherein the at least one electrical connection element is configured to be detachably connected to at least one connector plug of a connecting cable leading to the at least one first medical electrode and wherein the at least one electrical connection element is arranged in a vicinity of a receiving region for the at least one first medical electrode to be checked.
33. The testing device according to claim 32 when dependent on any one of claims 4 to 10, wherein the connecting cable leads to both the at least one first medical electrode and to the second medical electrode.
34. The testing device according to any one of claims 4 to 10, wherein at least one electrical connection element is provided, wherein the at least one electrical connection element is configured to be detachably connected to at least one connector plug of a connecting cable leading to the second medical electrode, and wherein the at least one electrical connection element is arranged in a vicinity of a receiving region for one of or both (1) the at least one first medical electrode to be checked and (2) the second medical electrode to be checked.
35. The testing device according to any one of claims 22 to 34, wherein the at least one electrical connection element is connected to the signal generating device.
36. The testing device according to any one of claims 1 to 35, wherein the at least one first measuring electrode and the at least one first medical electrode are different and distinct from each other.
37. The testing device according to any one of claims 1 to 36, wherein the at least one first medical electrode is configured to be brought into contact with skin of a patient.
38. Use of a testing device, which is separate from skin of a patient, according to any one of claims 1 to 37 for checking at least one medical electrode before it is applied to the skin of the patient.
39. Use of a testing device according to any one of claims 1 to 37 for testing the at least one first medical electrode together with connecting cables(s) of the at least one first medical electrode, wherein the alternating voltage from the signal generating device is applied to the at least one first medical electrode via the connecting cable(s).
40. Use of a testing device according to any one of claims 1 to 37, for testing the at least one first medical electrode together with connecting cable(s) of the at least one first medical electrode and present connector plugs, wherein the alternating voltage from the signal generating device is applied to the at least one first medical electrode via the connecting cable(s) and the connector plug(s).
41. Use of a testing device according to any one of claims 1 to 37 for checking the at least one first medical electrode wherein the at least one first medical electrode is located in a closed package.
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PCT/AT2017/060138 WO2017201560A1 (en) | 2016-05-27 | 2017-05-24 | Testing device for checking at least one first medical electrode |
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WO2020227066A1 (en) * | 2019-05-03 | 2020-11-12 | Galvani Bioelectronics Limited | Non-destructive test fixture for screening electrical continuity |
WO2021217205A1 (en) * | 2020-04-28 | 2021-11-04 | Seer Medical Pty Ltd | Testing apparatus and method |
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CN109195660B (en) | 2022-08-19 |
AT518762A1 (en) | 2017-12-15 |
AT518762B1 (en) | 2021-06-15 |
CA3025405A1 (en) | 2017-11-30 |
CN109195660A (en) | 2019-01-11 |
EP3463568A1 (en) | 2019-04-10 |
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Effective date: 20181123 |